With clock ticking on Teva migraine drug, analyst expresses doubt for approval

With time running short before the Sept. 16 PDUFA date for Teva's injected migraine drug candidate, questions remain about whether the manufacturing plant is ready. (CC0 Creative Commons/Pixabay)

Teva executives continue to express confidence the drugmaker's novel migraine drug will get an FDA nod next week, but with questions lingering about the Celltrion manufacturing plant that will produce it, at least one analyst is writing it off for now.

Teva CEO Kåre Schultz in a meeting earlier this month with analysts at EvercoreISI indicated it was "more likely than not" that fremanezumab, which has already been pushed back three months, would get approved on its Sept.16 PDUFA date, analyst Umer Raffat wrote in a note. But Schultz and other Teva execs acknowledged “it could be approved or not,” Raffat wrote.